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Completed

NCT Number: NCT04523129

ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CYS-004 Investigational Site, Phoenix, Arizona, United States

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About this study

This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed ICF (Informed Consent Form)
  • Patient-reported history of DED in both eyes
  • Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms
  • Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion criteria

  • Women who are pregnant, nursing or planning a pregnancy
  • Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
  • Clinically significant slit-lamp findings or abnormal lid anatomy at screening
  • Ocular/periocular malignancy
  • History of herpetic keratitis
  • Active ocular allergies or ocular allergies that may become active during the study period
  • Ongoing ocular or systemic infection at screening or baseline
  • Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
  • Use of topical Cyclosporine A or Liftigrast within 2 months prior to screening
  • Intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
  • Presence of uncontrolled systemic diseases
  • Presence of known allergy and/or sensitivity to the study drug or its components
  • Randomized in a previous CyclASol trial

Treatment and study plan

CyclASol topical ocular, eye drops

Drug

Cyclosporine A solution in vehicle

Other names: Ciclosporine (CSA)

Vehicle topical ocular, eye drops

Drug

Vehicle

Other names: Vehicle

Primary outcomes

  1. Change From Baseline in Total Corneal Fluorescein Staining

    Time frame: baseline and 1 month [day 29]

    Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).

  2. Change From Baseline in Eye Dryness Score

    Time frame: baseline and 1 month [day 29]

    Eye dryness score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.

Secondary outcomes

  1. Change From Baseline in Total Conjunctival Lissamine Green Staining

    Time frame: baseline and 1 month [day 29]

    Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye.

  2. Proportion of Responders in Central Corneal Fluorescein Staining Score

    Time frame: baseline and 1 month [day 29]

    ≥ 1 score improvement for cCFS on National Eye Institute (NEI) scale: Central Corneal Fluorescein Staining (cCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).

  3. Proportion of Responders in Total Corneal Fluorescein Staining Score

    Time frame: baseline and 1 month [day 29]

    ≥ 3 scores improvement for tCFS on National Eye Insititute (NEI) scale: Total Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) -15 (worst).

  4. Change From Baseline in Central Corneal Fluorescein Staining

    Time frame: baseline and 1 month [day 29]

    Central Corneal Fluorescein Staining (cCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).

  5. Change From Baseline in Total Corneal Fluorescein Staining

    Time frame: baseline and 2 weeks [day 15]

    Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).

  6. Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision

    Time frame: baseline and 1 month [day 29]

    Blurred vision score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.

Sponsors and collaborators

Lead sponsor

Novaliq GmbH

Industry

Registry information

Official study title

A Phase 3, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Dry Eye Disease

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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